polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid (MoviPrep)

Dosing and uses of MoviPrep (polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid)

• Adult
• Pediatric

 

Adult dosage forms and strengths

polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid

oral powder for solution

• After reconstitution (of 4 packets/2L) contains Pouch A (100g PEG 3350, 7.5 g sodium sulfate, 2.69g sodium chloride, 1.015 g potassium chloride), and Pouch B (4.7 g ascorbic acid, and 5.9 g sodium ascorbate)

Four separate pouches in kit (2 of pouch A and 2 of pouch B)

1 pouch A and 1 pouch B are dissolved together in water to a volume of 1 L for oral use

 

Gastrointestinal Lavage

Cleansing of the colon as preparation for colonoscopy in 18 yrs and older: 2 L PO prior to colonoscopy

Split-dose regimen

• Evening before colonoscopy: 1 L PO over 1 hr (240 mL q 15 min)
• Follow with 0.5 L (480mL) clear fluid
• Morning of colonoscopy: At least 3.5 hr before colonoscopy, drink 1 L PO over 1 hr (240 mL q 15 min)
• Follow with 0.5 L (480mL) clear fluid at least 1 hr prior to colonoscopy

Full-dose regimen

• 6 PM the evening before colonoscopy: 1 L PO over 1 hr (240 mL q 15 min)
• Approximately 1.5 hrs later, 1 L PO over 1 hr (240 mL q 15 min)
• Follow with 1 L additional clear liquid during the evening before colonoscopy

 

Renal Impairment

Pharmacokinetics have not been studied in patients with renal or hepatic insufficiency

 

Administration

PEG/electrolyte Solution Preparation

• Prepare solution by emptying contents of 1 pouch A and 1 pouch B into a suitable glass container (or the container provided) and adding to the container 1 L lukewarm water
• Mix the solution to ensure that the ingredients are completely dissolved
• Solution can be refrigerated prior to drinking
• Reconstituted solution should be used within 24 hours
• After consumption of the first liter of solution, the above mixing procedure should be repeated with the second pouch A and pouch B to reconstitute the second liter
• No additional ingredients (eg, flavorings) should be added to the solution

 

Pediatric dosage forms and strengths

Safety and efficacy not established in pediatrics

 

MoviPrep (polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid) adverse (side) effects

>10%

Split-dose

• Malaise (18-27%)
• Nausea (14-47%)
• Abdominal pain (13-39%)
• Vomiting (17 -12%)

Full-dose

• Abdominal distension (59.8%)
• Anal discomfort (51.5%)
• Thirst, nausea (47.3%)
• Abdominal pain (39.1%)
• Sleep disorder (34.9%)
• Rigors (33.7%)
• Hunger (30.2%)
• Malaise (26.6%)

 

1-10%

Split-dose

• Vomiting (7.8%)
• Upper abdominal pain (5.6%)
• Dyspepsia (2.8%)

Full-dose

• Vomiting (7.1%)
• Dizziness (6.5%)
• Headache (1.8%)

 

Frequency not defined

Rhinorrhea

Dermatitis

Urticaria

Anaphylactic reaction

Bloating

 

Postmarketing Reports

Cardiovascular: Tachycardia, palpitations, hypertension, arrhythmia, atrial fibrillation, peripheral edema

General: Hypersensitivity reactions including anaphylaxis (some of which were severe, including shock), rash, urticaria, pruritus, lip, tongue and facial swelling, dyspnea, chest tightness and throat tightness; fever, chills, and dehydration

Nervous system: Syncope, tremor, seizure

Renal: Renal impairment and/or failure

 

Warnings

Contraindications

Hypersensitivity

GI obstruction

Bowel perforation

Gastric retention

Ileus

Toxic colitis

Toxic megacolon

 

Cautions

Use with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities

Use with caution in patients with severe ulcerative colitis, ileus, gastrointestinal obstruction

Patients with impaired gag reflex and patients prone to regurgitation or aspiration should be observed during the administration

Since product contains sodium ascorbate and ascorbic acid, use with caution in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency

If severe vomiting occurs, check serum electrolytes

Phenylketonurics: product contains phenylalanine

Serious arrythmias reported

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Unknown whether distributed in breast milk, caution advised

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of MoviPrep (polyethylene glycol/electrolytes/sodium ascorbate/ascorbic acid)

Mechanism of action

Elicits osmotic laxative effect and replenishes electrolytes; induces catharsis through strong electrolyte and osmotic effects

 

Absorption

Onset: 1-2 hr